It is important to maintain a sterile environment in situations where patient medical treatment can lead to complications from infection or non-sterile practices, especially in invasive diagnostic or therapeutic applications. One example where sterile practices and equipment are required is in the introduction of medical instruments, tools, diagnostic and therapeutic probes and similar devices (collectively referred to herein as “probes”), such as ultrasonic probes, which come in contact with a patient's body.
Conventional methods for sheathing a probe include application of a sterile sheath, for example a thin plastic film or condom, over the probe prior to placement of the probes on the patient's body or to a vulnerable sterile area. However, conventional methods for applying the sheath to the probe, and handling of the sheathed probe are less than ideal. For example, conventional methods and systems usually require more than one person to simultaneously handle the probe and apply the sheath to the probe. Also, conventional ways of sheathing a probe are prone to errors defeating the intended sterility of the probes and sheaths. In addition, wasted time in the clinical setting due to inefficient or ineffective applications of sheaths to probes results in wasted materials and in lost revenue for the medical institution or practice and reduced patient care opportunities, not to mention added health care costs to patients and society.
FIG. 1 illustrates a simplified non-sterile conventional setup 10 for sheathing a medical probe. A flexible sheath, such as an elongated furled sock, bag, condom or similar sheathing article 100 is held in one hand so as to form a depression, cavity or pocket-like recess therein 102. An amount of coupling gel 110 such as ultrasound coupling gel is dispensed from a gel packet or bottle 120. The gel facilitates the propagation of imaging or therapeutic energy waves (e.g., ultrasound) therethrough by eliminating air pockets between the active probe tip inserted into pocket 102 and the sheath 100, and by providing an impedance matched medium for effective transmission of such energy waves.
The assembly described above is normally supported by or carried on a wheeled cart so that operators can easily maneuver the probe, sheath and later the sheathed probe about.
FIG. 2 illustrates general steps 20 of sheathing a medical probe according to the prior art using an apparatus like the one illustrated in FIG. 1. Sterile gloves (sometimes called personal protective equipment or PPE) are donned by the operator at step 200. The operator removes the sheath from its packaging and holds it open at step 202, usually by grasping the collapsed sheath in one hand and using the second hand to create a crater-like inverted opening therein. The operator then squeezes an amount of sterile gel into the inverted opening of the sheath. This step must be done while holding the opened inverted sheath, so it can be awkward to perform with one hand, especially if the operator forgets to tear open or stage the gel dispenser or packet in advance. Additionally, this sheath lacks a clear orientation to assist the user in applying it. Any mistakes in grasping items by the operator during this procedure can lead to inadvertent breach of sterility. Also, the gel must be sterile since the user has donned his or her PPE at this time. The operator then must grasp the probe tip through the sheath while maintaining sterility at step 206. The sheath is unfurled, usually with the aid of a second operator or assistant at step 208. Steps 206 and 208 are particularly susceptible to breaches of sterility, especially if the operators are not highly expert at the procedure, which leads to increased risk of contamination and infection. Step 206 is typically a two-person operation, which leads to inefficiency, delay, and added liability and operating costs to the clinic and its patients.
A modern hospital can utilize between ten thousand and twenty thousand probe sheathing kits annually. With thousands of such hospitals and clinics in operation in the United States, it can be appreciated that effective, safe and economical sheathing devices and methods are of great use to the medical industry and the general public.
The present inventors have recognized a number of shortcomings of existing systems and methods for sheathing medical probes to which the following disclosure is directed.